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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01173120




Registration number
NCT01173120
Ethics application status
Date submitted
28/07/2010
Date registered
30/07/2010
Date last updated
12/01/2012

Titles & IDs
Public title
Methotrexate - Inadequate Response Device Sub-Study
Scientific title
Sub-study-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Secondary ID [1] 0 0
2007-005434-37
Secondary ID [2] 0 0
IM101-174 (Sub study)
Universal Trial Number (UTN)
Trial acronym
MTX-IR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Abatacept combination product (ACP)

Experimental: Abatacept Combination Product (ACP) - Participants from the long-term period of study NCT00559585 who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).


Treatment: Devices: Abatacept combination product (ACP)
Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation
Timepoint [1] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months
Primary outcome [2] 0 0
Number of Participants With AEs of Special Interest in the ACP Device Substudy
Timepoint [2] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose
Primary outcome [3] 0 0
Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy
Timepoint [3] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [4] 0 0
Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
Timepoint [4] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [5] 0 0
Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
Timepoint [5] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [6] 0 0
Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
Timepoint [6] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [7] 0 0
Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
Timepoint [7] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [8] 0 0
Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy
Timepoint [8] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [9] 0 0
Mean Heart Rate Over Time in the ACP Device Substudy
Timepoint [9] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Primary outcome [10] 0 0
Mean Temperature Over Time in the ACP Device Substudy
Timepoint [10] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
Secondary outcome [1] 0 0
Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy
Timepoint [1] 0 0
Days 1, 29, 57, 85, 169, and 253 of ACP substudy
Secondary outcome [2] 0 0
Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy
Timepoint [2] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose
Secondary outcome [3] 0 0
Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy
Timepoint [3] 0 0
ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose

Eligibility
Key inclusion criteria
* Men and women, ages = 18
* Participants who are considered methotrexate inadequate responders (MTX-IR)
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
* Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
* Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
* Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Participants with severe chronic or recurrent bacterial infections
* Participants who have received treatment with rituximab

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.
Trial website
https://clinicaltrials.gov/study/NCT01173120
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01173120